mi-eye 2 160mm

GUDID 00861578000362

mi-eye 2 probe 160mm length for use with Trice Tablet 2

TRICE MEDICAL, INC.

Rigid arthroscope, single-use

• Primary Device ID: 00861578000362
• NIH Device Record Key: 79d3e934-d3a3-43f6-87ea-50a917a70b88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mi-eye 2 160mm
• Version Model Number: T200-160
• Company DUNS: 009452895
• Company Name: TRICE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 610-989-8080
• Email: customerservice@tricemedical.com
• Phone: 610-989-8080
• Email: customerservice@tricemedical.com
• Phone: 610-989-8080
• Email: customerservice@tricemedical.com
• Phone: 610-989-8080
• Email: customerservice@tricemedical.com
• Phone: 610-989-8080
• Email: customerservice@tricemedical.com
• Phone: 610-989-8080
• Email: customerservice@tricemedical.com
• Phone: 610-989-8080
• Email: customerservice@tricemedical.com
• Phone: 610-989-8080
• Email: customerservice@tricemedical.com
• Phone: 610-989-8080
• Email: customerservice@tricemedical.com
• Phone: 610-989-8080
• Email: customerservice@tricemedical.com
• Phone: 610-989-8080
• Email: customerservice@tricemedical.com
• Phone: 610-989-8080
• Email: customerservice@tricemedical.com
• Phone: 610-989-8080
• Email: customerservice@tricemedical.com
• Phone: 610-989-8080
• Email: customerservice@tricemedical.com
• Phone: 610-989-8080
• Email: customerservice@tricemedical.com
• Phone: 610-989-8080
• Email: customerservice@tricemedical.com
• Phone: 610-989-8080
• Email: customerservice@tricemedical.com
• Phone: 610-989-8080
• Email: customerservice@tricemedical.com

Device Dimensions

• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter
• Length: 95 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861578000362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162475

FDA Product Code

• HRX: Arthroscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-20

Devices Manufactured by TRICE MEDICAL, INC.

• 00857356008026 - mi-eye 2: 2023-11-17 MI-EYE 2 SYSTEM, MI-ULTRA, EN
• 00857356008118 - mi-eye 2: 2023-11-17 TRICE MI-EYE ANGLED NEEDLESCOPE, 120MM
• 00857356008224 - mi-tablet 3: 2023-11-17 mi-tablet 3
• 00857356008231 - mi-eye 3: 2023-11-17 mi-eye 3 needlescope, 95mm
• 00857356008248 - mi-eye 3: 2023-11-17 mi-eye 3 angled scope, 120mm
• 00857356008255 - mi-eye 3: 2023-11-17 mi-eye 3 25 deg scope, 75mm with cannula
• 00857356008262 - mi-eye 3: 2023-11-17 mi-eye 3 scope, 95mm with cannula
• 00857356008279 - mi-eye 3: 2023-11-17 mi-eye 3 25° scope, 75mm with cannula